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Questions in bold text are mandatory. (*)

Request Number:

81698

Current Page:

Review

Trial from ANZCTR

Trial ID

ACTRN12607000123448

Trial Status:

Registered

Date Submitted:

20/11/2006

Date Registered:

12/02/2007

Retrospectively registered

Page 1

A randomised control trial to evaluate the effects of a community-wide approach (including health, law enforcement and education groups) on reducing alcohol-related problems in rural communities in NSW.

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Reason:

UTN

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Trial acronym

AARC-RCT

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Page 2

Health condition(s) or problem(s) studied:

Alcohol-related problems in rural communities in NSW16150

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Reason:

Condition category:

Condition code:

Public Health

Other public health

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Update:

Reason:

1723172300

Page 3

Descriptions of intervention(s) / exposure

This trial compares a systematic, community-wide approach to reducing alcohol-related problems (including health, police, legal and education groups) in experimental communities, versus 'usual practice' in matched control communities. The intervention will comprise a number of simultaneously implemented strategies over a three to four year period, including feedback of alcohol-related information via local media, high school education sessions, GP training in brief intervention, vocational programs targeting high-risk individuals and hospital-based alcohol interventions.

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Reason:

Intervention Code:

Other interventions14520

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Reason:

Comparator / control treatment

The control communities will continue to implement their existing programs (treatment as usual), but will not recieve the strategic, community-wide approach.

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Control group

Active

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Page 4

Primary Outcome:

Reductions in alcohol-related criminal incidents23910

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Reason:

Timepoint:

These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.23910

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Reason:

Primary Outcome:

Reductions in alcohol-related traffic accidents23920

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Reason:

Timepoint:

These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.23920

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Reason:

Primary Outcome:

Reductions in alcohol-related emergency department presentations23930

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Reason:

Timepoint:

These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.23930

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Reason:

Primary Outcome:

Reductions in alcohol-related hospital inpatient admissions. 23940

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Reason:

Timepoint:

These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.23940

These will be measured at the time the relevant intervention strategy is implemented on a pre- and post-test basis only (ie: they will not be measured on an ongoing basis in the same way that the primary outcomes will be).41570

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Reason:

Page 5

Key inclusion criteria

Communities must be in NSW; have a population size between 8,000 and 20,000

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Reason:

Minimum age

No limit

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Reason:

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Maximum age

No limit

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Reason:

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Gender

Both males and females

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Healthy volunteers?

No

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Reason:

Key exclusion criteria

Communities must be more than 70km from a major urban or regional centre; experimental and control communities must be at least 100km apart; and communities must not be involved in any other community-wide intervention studies.

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Reason:

Page 6

Study type

Interventional

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Reason:

Purpose of the study

Prevention

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Allocation to intervention

Randomised controlled trial

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Reason:

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Twenty rural communities in NSW met all inclusion/exclusion criteria. Random allocation to experimental or control was done centrally by a statistician not involved in selecting communities

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Reason:

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)

Eligible communities were stratified into matched pairs (based on age, sex and Indigenous characteristics) and one of each matched pair was allocated to the experimental condition by simple computer random number generation

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Reason:

Masking / blinding

Open (masking not used)

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Reason:

Who is / are masked / blinded (choose all that apply)

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Reason:

Assignment

Parallel

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Reason:

Other design features

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Type of endpoint(s)

Efficacy

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Statistical Methods/Analysis

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Page 7

Phase

Phase 2 / Phase 3

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Reason:

Anticipated date of first participant enrolment

31/12/2004

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Reason:

Date of first participant enrolment

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Reason:

Anticipated date last participant recruited/enrolled

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Reason:

Actual date last participant recruited/enrolled

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Target sample size

20

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Recruitment status

Closed: follow-up continuing

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Reason:

Recruitment in Australia

Recruitment state(s)

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Reason:

Recruitment outside Australia

Page 8

Funding Source:

Charities/Societies/Foundations18720

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Reason:

Name:

Alcohol Education and Rehabilitation Foundation Ltd18720

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Reason:

Address:

18720

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Reason:

Country:

Australia18720

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Primary Sponsor

University

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Name:

The University of Newcastle

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Reason:

Address:

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Reason:

Country:

Australia

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Secondary Sponsor:

University16870

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Reason:

Name:

The University of NSW, National Drug and Alcohol Research Centre16870

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Reason:

Address:

16870

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Reason:

Country:

Australia16870

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Reason:

Page 9

Has the study received approval from at least one Ethics Committee?

Yes

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Reason:

Ethics Committee name:

University of Newcastle HREC-Corowa34800

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Reason:

Address:

34800

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Reason:

Country:

Australia34800

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Reason:

Approval Date:

10/03/200434800

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Reason:

Submitted Date:

34800

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Reason:

HREC:

H-752-020434800

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Reason:

Ethics Committee name:

University of Newcastle HREC-Forbes34810

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Reason:

Address:

34810

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Reason:

Country:

Australia34810

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Reason:

Approval Date:

10/03/200434810

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Reason:

Submitted Date:

34810

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Reason:

HREC:

H-752-020434810

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Reason:

Ethics Committee name:

University of Newcastle HREC-Grafton34820

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Reason:

Address:

34820

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Reason:

Country:

Australia34820

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Reason:

Approval Date:

10/03/200434820

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Submitted Date:

34820

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Reason:

HREC:

H-752-020434820

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Reason:

Ethics Committee name:

University of Newcastle HREC-Griffith34830

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Reason:

Address:

34830

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Reason:

Country:

Australia34830

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Reason:

Approval Date:

10/03/200434830

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Reason:

Submitted Date:

34830

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Reason:

HREC:

H-752-020434830

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Reason:

Ethics Committee name:

University of Newcastle HREC-Gunnedah34840

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Reason:

Address:

34840

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Reason:

Country:

Australia34840

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Reason:

Approval Date:

10/03/200434840

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Reason:

Submitted Date:

34840

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Reason:

HREC:

H-752-020434840

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Reason:

Ethics Committee name:

University of Newcastle HREC-Inverell34850

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Reason:

Address:

34850

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Reason:

Country:

Australia34850

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Reason:

Approval Date:

10/03/200434850

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Reason:

Submitted Date:

34850

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Reason:

HREC:

H-752-020434850

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Reason:

Ethics Committee name:

University of Newcastle HREC-Kempsey34860

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Reason:

Address:

34860

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Reason:

Country:

Australia34860

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Reason:

Approval Date:

10/03/200434860

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Reason:

Submitted Date:

34860

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Reason:

HREC:

H-752-020434860

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Reason:

Ethics Committee name:

University of Newcastle HREC-Leeton34870

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Address:

34870

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Reason:

Country:

Australia34870

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Reason:

Approval Date:

10/03/200434870

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Submitted Date:

34870

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Reason:

HREC:

H-752-020434870

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Reason:

Ethics Committee name:

University of Newcastle HREC-Parkes34880

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Reason:

Address:

34880

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Reason:

Country:

Australia34880

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Reason:

Approval Date:

10/03/200434880

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Reason:

Submitted Date:

34880

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Reason:

HREC:

H-752-020434880

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Reason:

Ethics Committee name:

University of Newcastle HREC-Tumut34890

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Reason:

Address:

34890

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Reason:

Country:

Australia34890

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Approval Date:

10/03/200434890

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Reason:

Submitted Date:

34890

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HREC:

H-752-020434890

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Brief summary

The primary purpose of the sudy is to reduce alcohol-related problems in selected rural communities in NSW by sytematically implementing a number of interventions across the whole community, involving numerous community groups, such as schools, police, health workers, GPs and road safety officers. It is anticipated that the communities involved in this process will reduce their number of alcohol-related problems by more than similar communities that are not involved in this process.

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Reason:

Trial website

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Trial related presentations / publications

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Public Notes

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Page 10

Principal Investigator

Title:

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Reason:

273860

Name:

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Reason:

273860

Address:

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Reason:

273860

Country:

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273860

Reason:

Tel:

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273860

Fax:

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273860

Email:

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273860

Contact person for public queries

Title:

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Reason:

106410

Name:

Dr Anthony Shakeshaft

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Reason:

106410

Address:

National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052

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Reason:

106410

Country:

Australia

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106410

Reason:

Tel:

+61 2 93850285

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106410

Fax:

+61 2 93850222

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106410

Email:

a.shakeshaft@unsw.edu.au

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106410

Contact person for scientific queries

Title:

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Reason:

15690

Name:

Dr Anthony Shakeshaft

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Reason:

15690

Address:

National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052